# FDA 483 - Unigen Inc. - Unknown Date

Source: https://www.globalkeysolutions.net/records/483/unigen-inc/eef4a797-0aad-472e-9352-ad660e96024a

> FDA 483 for Unigen Inc. on Unknown Date. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Unigen Inc.
- Product Type: biologics
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Unigen Inc. in Ibi District, Gifu, Japan, a biological drug substance manufacturer, revealed significant deficiencies in process validation, column re-use studies, and cleaning efficacy assessments. The inspection also identified inadequate procedures for preventing microbiological contamination, insufficient laboratory controls, and a lack of equipment qualification after shutdowns. These observations indicate a need for improved controls in critical manufacturing and quality control processes.

## Related Documents

- [483 - Unknown Date](https://www.globalkeysolutions.net/records/483/unigen-inc/d7287792-dc3d-4323-8ae8-286c20190550)

## Related Officers

- [Michele L. Forster](https://www.globalkeysolutions.net/people/michele-l-forster/5e4b6db7-412f-4e4f-87a9-8af15a16429f)
- [Robin Levis](https://www.globalkeysolutions.net/people/robin-levis/9f34a892-c3ce-4bac-a011-35a66a1e70e4)
- [Deborah Tross](https://www.globalkeysolutions.net/people/deborah-tross/4bb1492a-9845-411e-9fea-390feaad67c6)

Company: https://www.globalkeysolutions.net/companies/unigen-inc/55f10565-4316-44d5-802f-f7be056a8fa5

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd